Current through all regulations passed and filed through March 18, 2024
(A) Each registrant
shall develop, implement and maintain a written quality assurance program
in the form of a readily available manual or manuals,
either in hard copy format or electronic format. For purposes of this
chapter and Chapter 3701:1-67 of the Administrative Code, quality assurance
program means a program providing for verification by written procedures such
as testing, auditing, and inspection to ensure that deficiencies, deviations,
defective equipment, or unsafe practices, or a combination thereof, relating to
the use, disposal, management, or manufacture of radiation devices are
identified, promptly corrected, and reported to the appropriate regulatory
authorities.
(B) The written
quality assurance program of each registrant shall address and include records
to verify implementation of at least the following:
(1) The intervals of and procedures for the
evaluation of all radiation-generating equipment to ensure compliance with all
applicable rules of this chapter;
(2) Procedures for maintaining compliance
with occupational and public exposure limits;
(3) Procedures for notifying the director
when individuals are occupationally over exposed to radiation, pursuant to
Chapter 3701:1-38 of the Administrative Code;
(4) Safe operating procedures for each type
of radiation-generating equipment to be handled;
(5) Training of operators of each type of
radiation-generating equipment to be handled in order to assure competency in
the operating procedures;
(6) In
addition to the requirements of paragraph (B)(1) of rule
3701:1-38-10
of the Administrative Code, individuals likely to receive an annual
occupational dose in excess of one millisievert (one hundred millirem) shall be
instructed in the following:
(a) The
location, boundaries, and purpose of restricted areas; and
(b) A
description of the radiation-generating equipment and its location;
(7) The quality control tests to
be performed, the frequency of the quality control tests to be performed and
the personnel responsible for the performance of the quality control tests as
applicable to the radiation-generating equipment type and use;
(8) Policies regarding the state licensure or
certification of each person operating radiation-generating equipment as
required by Chapters 4773. and 4715. of the Revised Code;
(9) The dissemination of quality assurance
policies and a method to educate affected workers on those policies and any
policy changes;
(10) Radiation
workers' role and responsibility for following and supporting the quality
assurance program;
(11) Policies
regarding personnel protection, including time, distance, and
shielding;
(12) Policies regarding
occupational exposure of pregnant workers;
(13) Policies regarding radiation safety
training for ancillary personnel;
(14) Policies regarding training for
personnel with quality control responsibilities;
(15) Policies regarding
human patient protection, including screening for
pregnancy, exposure of pregnant patients, patient shielding, patient
education;
(16)
Policies
regarding verification of human patient identity and exam to be performed,
including identification of the appropriate body part;
(17)
Policies to only
permit licensed practitioners to order radiographic
examinations;
(18)
An inventory of radiation-generating equipment,
including the location and description of each unit.
(C) In addition to the requirements of
paragraphs (A) and (B) of this rule, the quality
assurance program of hospital registrants shall comply with the following:
(1) A certified radiation expert shall
conduct oversight and maintenance of quality assurance programs for hospital
registrants, by:
(a) Auditing the quality
assurance program on an annual basis;
(b) Performing reviews of the
quality assurance program each quarter;
(c) Completing and submitting all required
information with the annual audit form in accordance with paragraph (C)(6) of
this rule;
and
(d) Serving on the quality assurance
committee;
(2) Employees working in the radiation areas
shall be made aware of the identity, scope of authority, and a method for
contacting the certified radiation expert and the individual responsible for
radiation protection. This information, or a specific location where this
information may be obtained, shall be conspicuously posted in each area where
radiation-generating equipment is used;
(3) Each
hospital registrant shall establish a quality assurance committee for the
management of the quality assurance program. The members of the quality
assurance committee shall be approved by an executive administrator. Committee
meetings may be attended by the members or similarly qualified, designated
alternates. The quality assurance committee shall include at least the
following members:
(a) A member of the
hospital's executive administration;
(b) The individual responsible for radiation
protection;
(c) A radiologist or
radiation oncologist;
(d) A
certified radiation expert representing each of the following as applicable in
each hospital;
(i) Radiation therapy
services,
(ii) Mammography,
or
(iii) Diagnostic radiography
other than mammography; and
(e) A management representative of each
department of the hospital which has responsibilities involving the handling of
radiation-generating equipment;
(4) The quality assurance committee shall
meet as often as is deemed necessary to carry out its duties, but at least
once each quarter. To establish a quorum at least
one-half of the committee's membership must be present either in person or by
telecommunication , and must include
the individual responsible for radiation protection for the hospital, and the
member of the executive administration of the hospital. In addition, each
member must attend at least one quarterly meeting each calendar year. A record
of each meeting shall be maintained and distributed to each member which shall
include the following:
(a) The date of the
meeting;
(b) An indication of
members present; and
(c) A summary
of meeting including any recommended actions and ALARA reviews;
(5) Each quarter, the certified
radiation expert shall submit, to each appointed quality assurance committee
member, a review of the quality assurance program, which
shall contain, as applicable:
(a) Radiation
safety policy revisions proposed by the certified radiation expert;
(b) A review of occupational exposure records
by the certified radiation expert;
(c) Radiation safety incidents;
(d)
Performance evaluation summaries
for
radiation-generating equipment including a description of any issues
found; and
(e) Any corrective
actions recommended by the certified radiation expert that are necessary to comply with the requirements of
this chapter;
(6) The quality assurance program shall be
audited at least annually by a certified radiation expert. The certified
radiation expert shall develop a written report of the audit findings on forms
prescribed by the director and submit the report to the quality assurance
committee within thirty days of completing the audit. The quality assurance
committee shall review the audit report and implement any corrective actions
determined to be necessary. The certified radiation expert shall file the audit
report with the director within ninety days of completing the audit. Every
audit report shall include a determination of whether the quality assurance
program properly addresses the matters described in this rule and whether it is
being carried out in accordance with the written quality assurance program, and
any corrective actions to be taken to comply with the requirements of this
chapter. The audit report shall become a part of the inspection
record.
(D)
In
addition to the requirements of paragraphs (A) and (B) of this rule, the
quality assurance program of registrants performing fluoroscopically-guided
interventional other than veterinary procedures, and computed tomography (CT)
other than veterinary and cone beam CT procedures shall establish a radiation
dose review committee in accordance with the following:
(1)
The
registrant may establish a system-wide committee if the registrant has more
than one site;
(2)
If the registrant is a subsidiary of a hospital, the
requirements of paragraph (D) of this rule may be delegated to the hospital
quality assurance committee provided its members meet the requirements of
paragraph (D)(3) of this rule;
(3)
The radiation
dose review committee shall include at least the following members:
(a)
The individual
responsible for radiation protection;
(b)
A diagnostic
radiation expert;
(c)
As applicable, a physician that performs
fluoroscopically-guided interventional and/or computed tomography procedures;
and
(d)
As applicable, a technologist that performs
fluoroscopically-guided interventional and/or computed tomography
procedures;
(4)
A quorum
of the radiation dose review committee shall meet as often as necessary to
carry out its duties, but at least annually. To establish a quorum at least
one-half of the committee's membership must be present either in person or by
telecommunication, and must include the individual responsible for radiation
protection. A record of each meeting shall be maintained and include the
following:
(a)
The date of the meeting;
(b)
An indication of members present; and
(c)
A summary of
meeting including any recommended actions;
(5)
The radiation dose review committee for
fluoroscopically-guided interventional procedures shall establish and implement
written policies that include but are not limited to the following:
(a)
Identification of
individuals who are authorized to use fluoroscopic systems for interventional
purpose;
(b)
A method to be used to monitor patient radiation dose
during fluoroscopically-guided interventional procedures;
(c)
Dose notification
levels, as appropriate, at which the physician is notified and appropriate
actions are taken for patient safety;
(d)
Substantial
radiation dose level values following nationally recognized
standards;
(e)
Actions to be taken for cases when a substantial
radiation dose level is exceeded which may include patient follow-up;
and
(f)
Reviewing policies identified in paragraphs (C)(5)(a)
to (c)(5)(e) of this rule at least annually;
(6)
The radiation dose review committee
for computed tomography shall determine and review written protocols to improve
image quality and minimize patient dose. The review shall include acquisition
and reconstruction protocols, image quality, and radiation dose. At a minimum,
the review shall be performed annually and include the following clinical
protocols, if performed:
(a)
Pediatric head;
(b)
Pediatric
abdomen;
(c)
Adult head;
(d)
Adult
abdomen;
(e)
Adult chest; and
(f)
Brain
perfusion.
(E)
Records required
by this chapter and Chapter 3701:1-67 of the Administrative Code shall be
maintained in accordance with the following:
(1)
Data and test
results of evaluations and calibrations of all radiation-generating equipment
for no less than five years;
(2)
Data and test
results of evaluations of shielding and surroundings of all
radiation-generating equipment until the director terminates the registration
or five years after the equipment is transferred or disposed;
(3)
Maintenance logs
for radiation-generating equipment for five years;
(4)
Medical event
reports involving radiation exposure to individuals for all
radiation-generating equipment until the director terminates the
registration;
(5)
Copies of current licenses or the department's
licensure verification web page for everyone who is required to possess a
license at the facility; and
(6)
Biennial
calibration certificates or cross calibration documentation for all instruments
used to perform area radiation surveys, calibrations, and evaluations for five
years.